POS0841 EFFECTIVENESS AND SAFETY OF UPADACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR TNF-THERAPY IN GERMANY. FINAL RESULTS FROM A POST-MARKETING OBSERVATIONAL STUDY
Authors: T. Witte, U. Kiltz, F. Haas, E. Riechers, D. Adolf, U. Prothmann, U. Soppa, A. Roessler, K. Götz, B. Fritz, K. Krueger
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> The efficacy and safety of Upadacitinib (UPA), a selective Janus kinase inhibitor, have been evaluated in the SELECT clinical trial program <sup>[1-6]</sup>. The UPwArds study was designed to further elucidate UPA's real-world effectiveness in daily clinical practice. <h3>Objectives</h3> To assess UPA effectiveness and safety after a treatment period of 12 months in three different RA patient groups: i) the total patient population, ii) patients with previous failure of TNFi (prior TNFi), and iii) patients naïve to targeted-synthetic or biological disease-modifying anti-rheumatic drugs (ts/bDMARDs naïve). <h3>Methods</h3> UPwArds is a prospective, open-label, multicenter, post-marketing observational study including adult patients with moderate-to-severe RA and an inadequate response or intolerance to at least one previous disease-modifying anti-rheumatic drug. At month 12 of the observational period, improvement of the DAS28(CRP), CDAI and the 0-10 numerical rating scale for overall pain (NRS pain) were assessed for the different patient populations specified above. In addition, the three patient population groups were evaluated regarding safety data concerning adverse events that were collected over the study period. Respective comparisons are presented as number of events per 100 patient-years, including confidence intervals. Data analysis was conducted as observed without imputation of missing values. <h3>Results</h3> From all initially enrolled patients (n<sub>total</sub> = 533, n<sub>prior TNFi</sub> =262, n<sub>ts/bDMARDs-naïve</sub> = 209), 371 completed the study (70%), of whom 175 and 148 were prior TNFi or ts/bDMARDs-naïve patients, respectively. At month 12, the proportion of patients achieving DAS28 &lt; 2.6, DAS28 ≤ 3.2, CDAI ≤ 2.8, CDAI ≤ 10, and NRS pain reduction ≥ 50% reflected comparable outcomes in all three patient groups (Figure 1). Although the number of any AE per 100 patient years was higher in prior TNFi patients, no significant differences were found in any particular AE category, including serious AEs or other AEs of particular interest (Table 1). <h3>Conclusion</h3> In a real-world setting, UPA demonstrated comparable effectiveness and safety in prior TNFi patients, ts/bDMARDs-naïve patients and the overall patient population. <h3>References</h3> [1]Smolen JS, et al. Lancet 2019;393:2303–11; [2]Burmester GR, et al. Lancet 2018;391:2503–12; [3]Genovese MC, et al. Lancet 2018;391:2513–24; [4]van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20; [5]Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800; [6]Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21. <h3>Acknowledgements</h3> AbbVie funded this study, contributed to its design, participated in data collection, analysis and interpretation of data. AbbVie and the authors thank all study investigators for their contributions and all patients that participated in this study. No honoraria or payments were made for authorship. Medical writing support was provided by Dr. Matthias Englbrecht and was funded by AbbVie. Statistical analysis was provided by Dr. Daniela Adolf, StatConsult GmbH, which was funded by AbbVie. <h3>Disclosure of Interests</h3> Torsten Witte Grant/research support from: Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Chugai, Gilead, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Roche, and UCB, Uta Kiltz Consultant of: Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer, Florian Haas Consultant of: Consultant of: AbbVie, Celgene, Novartis, and Pfizer, Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, Roche, and Sanofi Genzyme, Elke Riechers Consultant of: Consultant of: AbbVie, Chugai, Novartis, Janssen and UCB, Grant/research support from: Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Daniela Adolf Employee of: Daniela Adolf Employee of StatConsult and may own stock or options, Ulrich Prothmann Grant/research support from: Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Glaxo Smith Kline, Novartis, Pfizer, Roche, Sanofi, SOBI, and UCB, Ulf Soppa Employee of: Employee of AbbVie and may own stock or options, Alexander Roessler Employee of: Employee of AbbVie and may own stock or options, Konrad Götz Employee of: Employee of AbbVie and may own stock or options, björn fritz Employee of: Employee of AbbVie and may own stock or options, Klaus Krueger Grant/research support from: Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Gilead, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, and UCB.